Back to resultsSarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
Primary Purpose
Parkinson's Disease, Dyskinesia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sarizotan HCl
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Dyskinesia, L-dopa-induced dyskinesia
Eligibility Criteria
Inclusion Criteria: Male or Female The subject is an out-patient Age 30 years or above Dyskinesias present during more than 25% of the waking day Dyskinesias at least moderately disabling Written informed consent Exclusion Criteria: Pregnancy and/or lactation Participation in another study within the last 30 days Dementia or other psychiatric illness that prevents provision of informed consent History of allergic disorders such as asthma Known hypersensitivity to the study treatment(s) Known hypersensitivity to ACTH
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00314288
Brief Title
Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
Official Title
A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
EMD Serono
4. Oversight
5. Study Description
Brief Summary
The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Dyskinesia
Keywords
Parkinson's Disease, Dyskinesia, L-dopa-induced dyskinesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sarizotan HCl
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female
The subject is an out-patient
Age 30 years or above
Dyskinesias present during more than 25% of the waking day
Dyskinesias at least moderately disabling
Written informed consent
Exclusion Criteria:
Pregnancy and/or lactation
Participation in another study within the last 30 days
Dementia or other psychiatric illness that prevents provision of informed consent
History of allergic disorders such as asthma
Known hypersensitivity to the study treatment(s)
Known hypersensitivity to ACTH
Facility Information:
City
Fountain Valley
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California
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United States
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Sunnyvale
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United States
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Germany
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Germany
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Germany
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Germany
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Ulm
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Germany
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Wiesbaden
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Germany
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Budapest
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Gyor
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Miskolc
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Cambridge
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United Kingdom
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Newcastle
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United Kingdom
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Nottingham
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United Kingdom
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Sheffield
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United Kingdom
12. IPD Sharing Statement
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Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
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